Specifying and Treating Anxiety in Autism Research (STAAR) Study

About The Study

At least 50 percent of children with autism spectrum disorder (ASD) exhibit clinically significant anxiety symptoms. These are associated with increased social deficits, depression, irritability, and stereotyped and self-injurious behaviors. While it is clear that anxiety represents a substantial problem for those with ASD, there are important issues that need to be clarified before effective treatment becomes widespread. This project of the ACE will explore better ways to detect anxiety in children with ASD and determine whether cognitive behavioral therapy or medication can better alleviate their symptoms.

Participation in the study begins with 1-2 half day visits to the MIND Institute in Sacramento for behavioral and cognitive assessments. This is followed by 1-2 visits for practice on MRI procedures at the Imaging Research Center in Sacramento. After these visits, your eligibility for the study will be determined. If your child qualifies, he or she will be randomly assigned to a treatment group. There are two treatment groups: 1) treatment with a program of cognitive behavioral therapy, or 2) treatment with the medication sertraline (a so-called selective serotonin reuptake inhibitor or SSRI). One group will also receive a placebo medication (more information about these options can be found below). You will be asked to attend weekly appointments with your child for 16 weeks during the course of treatment. At the end of this treatment, we will ask your child to repeat behavioral testing and the MRI done at the start of the study to see if there has been any changes. You will also be asked to return for follow-up visits to see how your child is doing after the treatment is complete.

About The Treatments

Therapy

Cognitive-Behavioral Therapy (CBT) is a well researched, problem-solving, goal-directed therapy that examines and treats the relationships between thoughts, feelings, and behaviors that are maintaining the anxious feelings. The basic philosophy behind CBT is that if you change the way you think about anxiety-provoking situations, you can change the way you feel about them and thus reduce your overall anxiety. Many studies have shown that CBT can be effective in persons with ASD and anxiety. But, very few have tried this technique in children with autism and intellectual disability.The CBT we will provide in the STAAR study is intended specifically for individuals with ASD, and can be adapted for those with mild levels of intellectual disability. If placed in the CBT group, you and your child will attend weekly 1 1/2 hour therapy sessions at the MIND Institute for 16 weeks, using the Behavioral Interventions for Anxiety in Children with Autism (BIACA) program, a therapy curriculum which has been specifically adapted and designed for children with ASD. All BIACA treatment will be administered by well-trained and well-supervised psychologists.

Medication (Sertraline & Pill Placebo)

Sertraline is an SSRI antidepressant medication that may be used to help with anxiety and/or autism symptoms. A placebo will look the same as the sertraline pill, but will not contain any active medication ingredient. A placebo group is used to insure that any changes that are observed are due to the medication and not just to involvement in the study. If placed in the medication group, your child will be randomly assigned to take either sertraline or the placebo daily for 16 weeks. A medical doctor (MD) will start on a low dose to minimize side effects, and the dose will gradually be increased over the course of the study. The medication should be taken daily, and will be provided through the UC Davis Pharmacy. You will be asked to keep a medication log documenting when you give the daily medication, including any skipped doses. The study team will monitor your child throughout the course of the 16 weeks through a combination of clinic visits and phone calls. If your child experiences any side effects from the medication, the MD will make adjustments to help eliminate them.

Which treatment will my child get? Can I choose?

In this study, we will work hard to ensure that all people evaluating you and your child do not know the type of treatment you are receiving. This means that the treatment you get will be chosen by chance, like flipping a coin. Neither you, nor the study MD will choose what treatment you get. You will have an equal chance of being given each treatment. We use this “blinding” procedure so that neither you nor the MD can influence the results of the study.

We have put together the following materials to help you and your child understand and prepare for the components of this study: